FDA WARNING_LETTER - Sleeping Bear Apiaries - June 03, 2008

On October 22, 2008, the FDA issued Warning Letter 2009-DT-04 to Sleeping Bear Apiaries following an inspection on June 2-3, 2008. The inspection and subsequent review of product labels and the firm's website (www.sleepingbearfarms.com) revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation is that the firm's "Michigan Montmorency 100% Pure Cherry Juice Super Concentrate" and "Real Raw Honey" products are marketed with claims that cause them to be unapproved new drugs. These claims, found on labels and the website, suggest the products can diagnose, cure, mitigate, treat, or prevent diseases. Examples for the cherry juice include fighting cancer, heart disease, arthritis, gout, and headaches, and for honey, treating MRSA and lowering cholesterol. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" requiring an approved New Drug Application (NDA) under Section 505 of the Act. Additionally, as drugs, they are misbranded under Section 502(f)(1) for lacking adequate directions for use.

Beyond being unapproved drugs, both products are also misbranded foods. The "Real Raw Honey" and "Michigan Montmorency 100% Pure Cherry Juice Super Concentrate" labels bear nutrient